336 Participants Needed

Multilevel HIV Prevention Strategy for Increasing PrEP Uptake

(STARR-NC Trial)

SE
Overseen BySarah E Rutstein, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new way to help people in rural and peri-urban North Carolina start using HIV prevention medication (PrEP). It includes personal help from a navigator, online educational resources, and telehealth services. The goal is to make it easier for people at STI clinics to get and use PrEP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be currently using PrEP to participate.

Is PrEP safe for humans?

PrEP, which includes medications like Truvada (emtricitabine/tenofovir disoproxil fumarate), is generally considered safe for humans. It has been approved by the FDA and is used to prevent HIV infection, with studies focusing on improving adherence and uptake rather than safety concerns.12345

Is PrEP generally safe for humans?

PrEP, which includes medications like Truvada (emtricitabine/tenofovir disoproxil fumarate), is FDA-approved and has been widely used to prevent HIV infection. While the studies focus on adherence and uptake, the approval and use of PrEP suggest it is generally considered safe for humans.12345

How does the HealthMpowerment Digital Health Intervention for increasing PrEP uptake differ from other treatments for HIV prevention?

The HealthMpowerment Digital Health Intervention is unique because it leverages mobile health (mHealth) technology to increase PrEP uptake among men who have sex with men (MSM), particularly targeting adolescents and young adults who are avid technology users. This approach is novel as it combines digital tools with traditional prevention strategies, aiming to reach populations that may not be effectively served by existing urban outreach efforts.678910

How does the HealthMpowerment Digital Health Intervention for increasing PrEP uptake differ from other treatments for HIV prevention?

The HealthMpowerment Digital Health Intervention is unique because it leverages mobile health (mHealth) technology to increase PrEP uptake among men who have sex with men (MSM), particularly targeting adolescents and young adults who are avid technology users. This approach is novel as it combines digital tools with traditional prevention strategies, aiming to reach populations not effectively covered by existing urban outreach efforts.678910

What data supports the effectiveness of the treatment HealthMpowerment Digital Health Intervention for increasing PrEP uptake?

Research shows that digital health tools, like mobile apps and online platforms, can effectively engage people in HIV prevention by providing real-time feedback and support, which may help increase adherence to PrEP (a medication to prevent HIV).134611

What data supports the effectiveness of this treatment for increasing PrEP uptake?

Research shows that digital health tools, like mobile apps and online services, can effectively engage people in HIV prevention and care, helping them stick to their medication schedules and access services more easily. These tools have been shown to improve adherence to PrEP, which is a medication taken to prevent HIV infection.134611

Who Is on the Research Team?

SR

Sarah Rutstein, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals assigned male at birth, aged 18-39, who have had sexual activity with a male in the past year and are not currently using PrEP. They must speak English, have daily smartphone access, and have tested HIV-negative within the last 90 days.

Inclusion Criteria

Have daily smartphone access
I have been sexually active with a male in the last year.
I was assigned male at birth.
See 3 more

Exclusion Criteria

Confirmed prior HIV-positive diagnosis
I have used PrEP medication in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Randomized trial of a multilevel HIV Pre-Exposure Prophylaxis (PrEP) intervention strategy in rural and peri-urban North Carolina STI clinics

3 years
Baseline and quarterly follow-up assessments

Intervention

Participants in the intervention arm receive a multilevel intervention including a PrEP Navigator, Digital Health Intervention platform, and referral to Telehealth PrEP services

6 months
Quarterly follow-up assessments

Control

Participants in the control arm receive standard PrEP referral services and a limited version of the Digital Health Intervention platform

6 months
Quarterly follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Quarterly follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • HealthMpowerment Digital Health Intervention - Basic
  • HealthMpowerment Digital Health Intervention - Enhanced
  • PrEP Navigation Services
  • Telehealth PrEP Services Referral
Trial Overview The study tests a strategy to increase PrEP use among participants. It includes randomized trials of PrEP Navigation Services, two versions of HealthMpowerment Digital Health Intervention (basic and enhanced), and Telehealth referrals over three years in rural North Carolina STI clinics.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: STARR NC Intervention ConditionExperimental Treatment3 Interventions
Group II: STARR NC Standard-of-Care Control ConditionActive Control1 Intervention

HealthMpowerment Digital Health Intervention - Basic is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Truvada for:
🇺🇸
Approved in United States as Truvada for:
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Approved in Canada as Truvada for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Published Research Related to This Trial

A study involving 71 HIV-negative adults using a digital health feedback system with ingestible-sensor-enabled Truvada® showed that 88.7% of participants adhered to the medication for at least 28 days, with an average adherence rate of 86.2%.
Adherence patterns indicated that older age and negative methamphetamine screens were associated with better adherence, suggesting that substance use may negatively impact the effectiveness of oral PrEP.
Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection.Browne, SH., Vaida, F., Umlauf, A., et al.[2023]
A systematic review of literature from 2013-2014 identified 23 published studies and 32 funded projects utilizing eHealth and mHealth strategies to enhance HIV prevention and care, indicating a growing trend in using technology for health interventions.
Despite the effective use of social media and other digital tools in engaging populations for HIV prevention, significant gaps still exist in ensuring patients are linked to care, retained in care, and initiated on antiretroviral therapy.
A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care.Muessig, KE., Nekkanti, M., Bauermeister, J., et al.[2022]
In a randomized clinical trial involving 229 MSM participants, providing automated feedback through a mobile app did not reduce the number of participants with poor adherence to preexposure prophylaxis (PrEP), with 16% in the intervention group showing poor adherence compared to 11% in the control group.
However, the app feedback significantly increased the proportion of participants achieving excellent adherence (48% in the intervention group vs. 31% in the control group), indicating that while it didn't help those struggling with adherence, it did support those already adhering well to PrEP.
Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application.van den Elshout, MAM., Hoornenborg, E., Achterbergh, RCA., et al.[2023]

Citations

Supporting the Art: Medication Adherence Patterns in Persons Prescribed Ingestible Sensor-enabled Oral Pre-Exposure Prophylaxis to Prevent Human Immunodeficiency Virus Infection. [2023]
A systematic review of recent smartphone, Internet and Web 2.0 interventions to address the HIV continuum of care. [2022]
Improving adherence to daily preexposure prophylaxis among MSM in Amsterdam by providing feedback via a mobile application. [2023]
Delivering HIV prevention medication online: Findings from a qualitative study exploring the acceptability of an online HIV pre-exposure prophylaxis (PrEP) care pathway among service users and healthcare professionals. [2023]
Mobile apps for HIV prevention: how do they contribute to our epidemic response for adolescents and young adults? [2021]
A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. [2019]
Feasibility, Acceptability, and Preliminary Efficacy of a Gamified Mobile Health Contingency Management Intervention for PrEP Adherence Among Black MSM. [2023]
Emerging technologies for HIV prevention for MSM: what we have learned, and ways forward. [2021]
DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Uptake and Acceptability of MyChoices: Results of a Pilot RCT of a Mobile App Designed to Increase HIV Testing and PrEP Uptake Among Young American MSM. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
The Roles of Technology in Primary HIV Prevention for Men Who Have Sex with Men. [2020]
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